Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06442085
Other study ID # RigaStradinsU
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2020
Est. completion date December 14, 2020

Study information

Verified date May 2024
Source Riga Stradins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study individual training with an immersive virtual reality Trauma Simulator was compared to live mannequin-based simulation training in a facilitated group. The results showed that virtual reality simulator led to non-inferior effects on trauma resuscitation skills to mannequin-based simulation. Trauma Simulator had good usability, was well received by the participants, and had minimal adverse effects.


Description:

Background: Despite its high potential, the effect of immersive virtual reality simulation (VRS) in trauma resuscitation training has not been studied. The aim of this study was to test the hypothesis that VRS is non-inferior to mannequin-based simulation (MBS) in trauma resuscitation training. Methods: In a single-center, randomized controlled non-inferiority trial, we compared individual training with an immersive virtual reality Trauma Simulator to live MBS training in a facilitated group. The primary outcome was the Trauma Score (ranging from 55 (worse) to 177 (best outcome)) during the MBS assessment. The secondary outcomes were the Trauma Score VRS assessment, System Usability Scale (ranging from 0 (worse) -100 (best outcome)), and Simulation Sickness Questionnaire (ranging from 0 (worse) to 235.62 (best outcome)).


Recruitment information / eligibility

Status Completed
Enrollment 38
Est. completion date December 14, 2020
Est. primary completion date September 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: fluency in English. Exclusion Criteria: history of motion sickness

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Teaching of trauma resuscitation by using virtual reality simulation
The intervention was teaching of trauma resuscitation by using VRS. Following welcome and a video lecture by Advance Trauma Life Support certified physician, the intervention group participants were orientated (15 minutes) to the VRS environment, head-mounted display (Oculus Rift S or Oculus Quest, Oculus, USA) and hand controllers by playing game First Steps (Oculus, USA). Then the participants were training by using the "Internal Hemorrhage" scenario in Trauma Simulator.
Teaching of trauma resuscitation by using mannequin based simulation
Volunteers were trained in groups of three or four by using mannequin-based rapid cycle deliberate practice simulation facilitated by a critical care physician. Next, the volunteers had 50 min training of the same trauma scenario as the intervention group. The simulation facility was set-up as close as possible to the virtual reality environment.

Locations

Country Name City State
Latvia Medical Education Technology Centre of Riga Stradins University Riga

Sponsors (1)

Lead Sponsor Collaborator
Riga Stradins University

Country where clinical trial is conducted

Latvia, 

References & Publications (2)

Bangor A, Kortum P: Determining what individual SUS scores mean: adding an adjective rating scale. Journal of Usability Studies. 2009;4:114-123.

Kennedy RS, Lane NE, Berbaum KS, Lilienthal MG: Simulator Sickness Questionnaire: an enhanced method for quantifying simulator sickness. The International Journal of Aviation Psychology. 1993;3:203-220.

Outcome

Type Measure Description Time frame Safety issue
Primary Trauma Score The primary outcome of the study is Trauma Score (range 55 (worst) to 177(best outcome) during an individual assessment in a mannequin-based simulation environment. The assessment was based on the video recordings analyzing students during performing in the scenario. The Trauma Score is an assessment tool developed by military emergency medicine experts for the Trauma Simulator. Within a Day
Secondary Trauma Score in VRS Trauma Score in the VRS environment served as a secondary outcome. System Usability Scale: a 10-item questionnaire (range 0-100, where 0 is the worst, 100 the best performance) was used to assess usability of Trauma Simulator. Within a VR session (less than 10minutes per person)
Secondary Pre- and Post-Surveys The students will receive pre and post surveys. The surveys are structured to evaluate students' experience before and after the training. As a reference, the evaluation tools are made, based on Bangor et al., 2009. A custom, six-question survey (5-point Likert scale) was used to assess the perception of Virtual Reality simulation before and after the study. Presence of cybersickness was evaluated by using Simulation Sickness Questionnaire (SSQ).15 SSQ assesses 16 symptoms of motion sickness in three domains: nausea (7 symptoms), disorientation (7 symptoms), and oculomotor effects (7 symptoms). Each symptom is self-reported as none (0), slight (1), moderate (2), and severe (3). Total Severity score is calculated as the sum of individual symptom scores in each domain multiplied by 3.74 in accordance with Kennedy et al. (1993), thus the final score ranges from 0 (worst) to 235.62 (best outcome). Within a Day
See also
  Status Clinical Trial Phase
Completed NCT05720819 - Biofeedback-VR for Treatment of Chronic Migraine N/A
Recruiting NCT05547152 - Evaluation of the Effectiveness of Virtual Reality Self-rehabilitation in the Treatment of Facial Paralysis and Synkinesis N/A
Recruiting NCT05528497 - Assessment of the Influence of the Virtual Reality Headset on Pain and Anxiety During Oocyte Retrieval Under Local Anesthesia N/A
Recruiting NCT05378581 - Use of Virtual Reality Mask During Blood and Skin Allergic Tests in 7 to 13 Children N/A
Completed NCT04091659 - Use of Virtual Reality for Overdose Management Educational Trainings N/A
Completed NCT04880486 - Weight Training With VR in Out-Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease N/A
Not yet recruiting NCT05982457 - The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching N/A
Completed NCT06061588 - "Potential Effects of Virtual Reality Technology on the Treatment of Migraine-Type Headaches" N/A
Completed NCT06112600 - The Impact of Virtual Reality and Kaleidoscope in Children During Vaccination N/A
Active, not recruiting NCT04532866 - Brain Changes in Response to Long-Duration Isolation and Confinement N/A
Completed NCT05604924 - Virtual Reality Training Simulator for Cesarean Section N/A
Recruiting NCT04736888 - Effectiveness of Extended Reality CPR Training Methods N/A
Not yet recruiting NCT05941390 - Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures N/A
Completed NCT05961033 - The Effects of Virtual Reality Based Exercises in Patients With Adhesive Capsulitis
Recruiting NCT04630184 - A Virtual Reality Exposure Intervention on Social Physical Anxiety in Women With Obesity N/A
Terminated NCT03665233 - Virtual Reality for Post Operative Pain Management After Total Knee Arthroplasty N/A
Recruiting NCT03698526 - Virtual Reality for Symptoms Control in Palliative Care N/A
Suspended NCT03715400 - Mobile Virtual Positive Experiences for Anhedonia N/A
Completed NCT03208400 - Virtual Reality Exposure in Spider Phobia N/A
Completed NCT05078762 - Immersive Virtual Reality in Simulation-based Bronchoscopy Training N/A